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510(k) K251156

NPseal by Guard Medical, Inc. — Product Code OKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2025
Date Received
April 15, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Device Class
Class II
Regulation Number
878.4683
Review Panel
SU
Submission Type

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

Other clearances by Guard Medical, Inc.

  • K250708 — NPseal (April 8, 2025)
  • K241522 — NPseal (20 and 25) (August 15, 2024)
  • K240244 — NPseal (Small, Medium, Large) (February 29, 2024)
  • K212971 — NPseal (February 10, 2022)
  • K211130 — NPseal (May 14, 2021)
  • K200305 — NPseal (May 26, 2020)

Other clearances for product code OKO

  • K250708 — NPseal (April 8, 2025)
  • K241522 — NPseal (20 and 25) (August 15, 2024)
  • K240244 — NPseal (Small, Medium, Large) (February 29, 2024)
  • K212971 — NPseal (February 10, 2022)
  • K211130 — NPseal (May 14, 2021)
  • K200305 — NPseal (May 26, 2020)
  • K193185 — Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (May 4, 2020)
  • K151710 — SNaP Wound Care System (November 19, 2015)
  • K142272 — SNaP Wound Care System (November 25, 2014)
  • K132080 — SNAP WOUND CARE SYSTEM (March 12, 2014)